Quantitative studies of the risk of serious hepatic injury in persons using nonsteroidal antiinflammatory drugs

Arthritis Rheum. 1997 Feb;40(2):201-8. doi: 10.1002/art.1780400204.


Objective: To quantify the risk of symptomatic hepatic injury associated with nonsteroidal antiinflammatory drugs (NSAIDs).

Methods: Five population-based studies were summarized to evaluate information on more than 1,000,000 patients using NSAIDs.

Results: The risk of clinically apparent liver injury was approximately 1 case per 10,000 patient-years of NSAID use. Only sulindac, associated with a 5-10-fold higher incidence of hepatic injury, differed significantly from other NSAIDs. Patients using diclofenac showed no higher incidence of serious liver disease than did patients using other NSAIDs.

Conclusion: Symptomatic hepatic effects attributable to most NSAIDs are extremely rare and usually mild.

Publication types

  • Review

MeSH terms

  • Anti-Inflammatory Agents, Non-Steroidal / adverse effects*
  • Chemical and Drug Induced Liver Injury*
  • Humans
  • Incidence
  • Liver Diseases / epidemiology*
  • Risk Factors


  • Anti-Inflammatory Agents, Non-Steroidal